by Steven M. Druker, J.D.
Executive Director of the Alliance for Bio-Integrity

Although most Americans (including those who serve in government) are unaware
of it, genetically engineered foods are on the market only because the U.S. Food
and Drug Administration (FDA) has covered up the warnings of its own scientists,
misrepresented the facts, and violated explicit mandates of U.S. law. The
following points provide the details and describe the solution.

The Food Additive Amendment of the U.S. Food, Drug and Cosmetic Act institutes
a precautionary approach and requires that new additives to food must be
demonstrated safe before they are marketed. (21 U.S.C. Sec. 321)

An official Senate report described the intent of the amendment as follows:
“While Congress did not want to unnecessarily stifle technological advances, it
nevertheless intended that additives created through new technologies be proven
safe before they go to market. (S. Rep. 2422, 1958 U.S.C.C.A.N. 5301- 2
(emphasis added))

Although the FDA admits that the various genetic materials implanted in bioengineered organisms are within the amendment’s purview, it claims they are
exempt from testing because they are generally recognized as safe (GRAS).

However, the FDA’s regulations state that substances added to food that were
not in use prior to 1958 cannot qualify as GRAS unless they meet two
requirements. Not only must they be acknowledged as safe by an overwhelming
consensus of experts, but this consensus must be based on “scientific
procedures” – which ordinarily entails studies published in peer-reviewed
journals. (21 CFR Sec. 170.30 (a-b) )

FDA regulations further stipulate that these scientific procedures must
provide a demonstration of safety and that GRAS substances “…require the same
quantity and quality of scientific evidence as is required to obtain approval of
the substance as a food additive.” (21 CFR Sec. 170.30(b)) Thus, it’s clear that
the GRAS exemption is not supposed to reduce the degree of testing but rather to
relieve a producer from performing new tests for substances already known to be
safe on the basis of previous ones.

Genetically engineered (GE) foods fail both requirements. There is substantial
dispute among experts about their safety; and none has been confirmed safe
through adequate testing.
As the FDA was developing its policy on GE foods during 1991- 92, there was
not even consensus of safety among its own experts. The predominant opinion was
(a) that these new foods entail unique risks, especially the potential for
unintended harmful side effects that are difficult to detect and (b) that none
can be considered safe unless it has passed rigorous tests capable of screening
for such effects. These scientists expressed their concerns in numerous memos to
superiors – memos that only came to light in 1998 when the Alliance for
Bio-Integrity initiated a lawsuit that forced the FDA to divulge its files.

For example, microbiologist Dr. Louis Pribyl stated: “There is a profound
difference between the types of unexpected effects from traditional breeding and
genetic engineering ….” He added that several aspects of gene- splicing “. . .
may be more hazardous . . .” (#4 in the set of photocopies of FDA memos at
www.biointegrity.org/list.html Numbers after subsequent quotes from FDA
scientists refer to the number in this set.) Similarly, Dr. E.J. Matthews of the
FDA’s Toxicology Group warned that “. . . genetically modified plants could …
contain unexpected high concentrations of plant toxicants…,” and he cautioned
that some of these toxicants could be unexpected and could “…be uniquely
different chemicals that are usually expressed in unrelated plants.” (2) Citing
the potential for such unintended dangers, the Director of FDA’s Center for
Veterinary Medicine (CVM) called for bioengineered products to be demonstrated
safe prior to marketing. He stated: “… CVM believes that animal feeds derived
from genetically modified plants present unique animal and food safety
concerns.” (10) (emphasis added) He explained that residues of unexpected
substances could make meat and milk products harmful to humans.

In light of these unique risks, agency scientists advised that GE foods should
undergo special testing, including toxicological tests. (e.g. 6, 10)

The pervasiveness of the concerns within the scientific staff is attested by
a memo from an FDA official who protested the agency was “… trying to fit a
square peg into a round hole . . . [by] trying to force an ultimate conclusion
that there is no difference between foods modified by genetic engineering and
foods modified by traditional breeding practices.” She declared: “The processes
of genetic engineering and traditional breeding are different, and according to
the technical experts in the agency, they lead to different risks.” (1)

Moreover, FDA officials knew there was not a consensus about the safety of GE
foods among scientists outside the agency either. For instance, FDA’s
Biotechnology Coordinator acknowledged in a letter to a Canadian health official
that there was no such consensus in the scientific community at large. He also
admitted, “I think the question of the potential for some substances to cause
allergenic reactions is particularly difficult to predict.” (8)

This lack of consensus in itself disqualifies GE foods from GRAS status. But
even if consensus did exist, no GE food would qualify as GRAS because none has
satisfactorily passed the level of testing that the law requires – and that the
FDA experts stated is necessary. The agency’s files demonstrate that as of 1992,
there was virtually no evidence to support safety, with one official’s memo to
the Biotechnology Coordinator querying: ” … are we asking the scientific experts
to generate the basis for this policy statement in the absence of any data?”(1).
And the evidentiary base is still deficient because the FDA does not require any
testing; and the tests relied on by the EU, Canada, and others do not adequately
screen for the unexpected side effects about which the FDA scientists warned.
The inadequacy of current testing has been pointed out by numerous experts,
including the Royal Society of Canada and the Public Health Association of
Australia.

Despite the ample evidence indicating a lack of consensus about safety, as
well as the lack of requisite evidence to confirm it, the FDA’s decision-makers
(who acknowledge they’ve been operating under a policy “to foster” the U.S.
biotechnology industry) declared it is legitimate to presume that all GE foods
are GRAS – and can therefore be marketed without any testing. In doing so, they
professed themselves “not aware of any information” showing that GE foods differ
from others “in any meaningful way,” despite the extensive input from their
scientists pointing out the significant differences and their serious
implications. (Statement of Policy: Foods Derived From New Plant Varieties, May
29, 1992, Federal Register vol. 57, No. 104 at 22991.)

Although many people have been led to believe that the U.S. district court in
Alliance for Bio-Integrity v. Shalala determined that GE foods are on the market
legally, its decision actually highlights the extent to which their presence is
contrary to the law.

In her written opinion, the judge stated: “Plaintiffs have produced several
documents showing significant disagreements among scientific experts.” 116
F.Supp.2d 166 (D.D.C. 2000) at 177. However, she ruled that the crucial issue
was not whether GE foods were in fact GRAS at the time of the lawsuit (or were
actually GRAS when the FDA issued its policy statement on GE foods in May 1992)
but whether FDA administrators had acted arbitrarily in 1992 in presuming that
they were GRAS. Therefore, because she held that the case hinged on this narrow
procedural issue of whether there had been adequate rational basis for the FDA’s
presumption, she said that any evidence showing lack of expert consensus at the
time of the lawsuit was irrelevant since it was not within the administrators’
purview when they formed their policy in 1992.

As for the evidence that had been within the FDA’s own files in 1992, she
ruled that the administrators were free to disregard the opinions of
subordinates when setting policy. (p.178) This conclusion seems odd, since the
written opinions of the agency’s scientists represented far more than mere
policy preferences. They constituted solid evidence that a significant number of
experts did not recognize GE foods as safe. Further, the judge did not mention
the fact that the FDA’s biotechnology coordinator had admitted there was not a
consensus within the scientific community, even though plaintiffs’ briefs had
repeatedly cited the relevant document.

Moreover, the judge also disregarded the fact (repeatedly pointed out to her)
that the FDA’s files demonstrated there was insufficient technical evidence
about safety to support a presumption that GE foods are GRAS. Although her
opinion initially acknowledged that such technical evidence is legally required,
she never returned to the issue – a highly irregular outcome.

Thus, the judge did not determine that GE foods are (or ever were) truly
GRAS. Nor did she determine that any has been demonstrated safe. She merely held
that given the evidence before them in 1992, FDA officials had not acted
arbitrarily in presuming that the foods were GRAS. Further, she emphasized that
their presumption is, as a matter of law, “rebuttable.” (p.172)

Regardless of whether one agrees that FDA administrators had reasonable basis
in 1992 to presume that GE foods are GRAS, it’s obvious this presumption has
been decisively rebutted, both by the ever-growing dispute among experts and the
ongoing lack of adequate testing.

Consequently, the marketing of GE foods in the U.S. is illegal because none
of them is GRAS and none has undergone formal food additive approval. To rectify
this situation, the FDA needs to acknowledge the truth, admit that GE foods are
not GRAS, and remove them from market. And it must not allow any such product to
be re-introduced until it has been confirmed safe through the testing required
by law. To do so, the agency does not have to reverse any official
determinations, because it has never formally determined that any GE food is
GRAS or that any has been demonstrated safe. It merely has to acknowledge that
its rebuttable presumption has been solidly rebutted. Otherwise, it will remain
in violation of the law – and will continue to deprive Americans of the
safeguards that Congress has explicitly mandated.

The following paragraphs more fully document the extent of the FDA’s
malfeasance.A. Addressing the extensive death and disability caused by a GE food
In 1989, the Japanese manufacturer Showa Denko K.K. began marketing a food
supplement of the amino acid L-tryptophan that was produced with genetically
engineered bacteria. As part of the process, several genes to substantially
increase the output of tryptophan were spliced into the bacterial DNA. Within a
few months of entering the U.S. market, the bioengineered supplement caused an
epidemic of an unusual malady (called EMS) that resulted in the deaths of dozens
of people and the permanent disability of at least 1,500 others.

For many preceding years, other manufacturers had marketed food grade L-tryptophan
supplements produced from bacteria without use of gene-splicing. Epidemiological
evidence from the Center for Disease Control does not link any tryptophan from
these other manufacturers with outbreaks of EMS. (Kilbourne, E. Journal of
Rheumatology Supplement, vol. 46, Oct. 1996) Further, Showa Denko’s
bioengineered tryptophan was found to contain numerous contaminants, at least
two of which were novel and had not been seen in any of those conventionally
produced batches. It is still not known which contaminant (or combination of
them) caused the epidemic.

Although there is no conclusive proof that EMS resulted from genetic
engineering, the link has not been ruled out; and many experts think it’s likely
that whatever toxin caused the disease was an unexpected side effect of the
gene-splicing procedure.

In private, FDA officials confirm that the bioengineering process might have
caused the EMS. On September 27, 1991, Dr. James Maryanski, Coordinator of FDA’s
Biotechnology Working Group, was questioned by staff of the GAO. According to
his record of the meeting: “I said that we have no new information, that we do
not yet know the cause of EMS nor can we rule out the engineering of the
organism.” Emphasis added. (FDA Administrative Record at 22,923) When I
questioned him in private eight years later, Dr. Maryanski again admitted that
bioengineering cannot be ruled out. (Personal conversation, Washington, D.C.
November 30, 1999)

FDA’s Public Response: On July 18, 1991, Dr. Douglas L. Archer, Deputy Director
of FDA’s Center for Food Safety and Applied Nutrition (CFSAN), testified before
the House of Representatives Subcommittee on Human Resources and
Intergovernmental Relations about the L-Tryptophan tragedy. He said the incident
confirmed the FDA’s warnings about the hazards of many health food supplements
and that the deaths and injuries “demonstrate the dangers inherent in the
various health fraud schemes that are being perpetrated on segments of the
American Public.” Dr. Archer’s prepared remarks never indicated that the toxic
batches of L-Tryptophan had been produced through genetic engineering, nor did
he once raise the possibility it was this process rather than any presumed
problems with L-Tryptophan supplements in general that was the cause of the
illnesses.

The FDA and other agencies of the federal executive branch continue to cloud the
fact that the fatal L-Tryptophan was derived through bioengineering and persist
in the false claim that no GE food has even been associated with a human health
problem.

B. Addressing the tests on the “Flavr Savr” tomato
The first GE whole food that the FDA reviewed was Calgene’s “Flavr Savr” tomato.
Although the FDA did not require testing, Calgene voluntarily subjected the
tomato to animal feeding studies and asked the agency to review the data. FDA
scientists noted a pattern of stomach lesions that raised a safety issue.
Further, seven of the rats fed one variety of the GE tomato died within two
weeks. Commenting on the data, Dr. Robert J. Scheuplein, director of the FDA’s
Office of Special Research Skills, wrote: “… the data fall short of ‘a
demonstration of safety’ or of a ‘demonstration of reasonable certainty of no
harm’ which is the standard we typically apply to food additives. To do that we
would need, in my opinion, a study that resolves the safety question raised by
the current data.”(15) Dr. Carl B. Johnson of the Additives Evaluation Branch
concurred that “… unresolved questions still remain.” (16)

It is noteworthy that FDA officials had instructed their experts to apply a
lower safety standard in evaluating the tomato than the standard used for new
food additives. (Scheuplein memo, p.4) In doing so, they violated the FDA’s own
regulations, which (as earlier noted) mandate that even foods claimed to be GRAS
“…require the same quantity and quality of scientific evidence as is required
to obtain approval of the substance as a food additive.” (21 CFR Sec. 170.30(b))
FDA Response: The agency claimed that all relevant safety issues had been
satisfactorily resolved and said that because the Flavr Savr had performed so
well, it would be unnecessary for any subsequent bioengineered food to be
subjected to the same standard of testing. To date, there is no reliable
evidence showing that any has satisfied the standard the Flavr Savr failed to
meet.

C. Addressing the use of antibiotic resistant marker genes
Because most cells subjected to gene implantation techniques fail to incorporate
the foreign gene, a large number must be used, and a marker must be attached to
the foreign gene in order to identify the cells that have taken it up. The
manufacturers decided that genes coding for resistance to anti-biotic chemicals
would be the most economical markers. They especially desired to use a gene that
confers resistance to kanamycin, a broad-spectrum antibiotic with a significant
medical use. On September 30, 1992, FDA’s Biotechnology Coordinator requested
the Division of Anti-Infective Drug Products to evaluate the proposed use of the
kanamycin resistance marker gene. (11) On December 3, 1992, the Division’s
experts submitted their written opinion. To emphasize their concern, they
capitalized all the letters in the key sentence of their conclusion: “IT WOULD
BE A SERIOUS HEALTH HAZARD TO INTRODUCE A GENE THAT CODES FOR ANTIBIOTIC
RESISTANCE INTO THE NORMAL FLORA OF THE GENERAL POPULATION.” Emphasis in
original (12) In sending the document to another FDA official, the Division’s
director included a cover letter titled, “The tomatoes that will eat Akron.”
(The first commercial use of the marker was planned for the Flavr Savr tomato.)
He said: “You really need to read this consult. The Division comes down fairly
squarely against the kan gene marker in the genetically engineered tomatoes. I
know this could have serious ramifications.” (12)

On March 30, 1993 the Division’s Supervisory Microbiologist sent a follow-up
memo to the Biotechnology Coordinator in which he strongly criticized the
proposed use of the marker. He noted that although other markers are available,
industry prefers the anti-biotic resistant ones because they are more
economical. He stated that to make the choice on this basis was wrong,
considering the risks involved: “In my opinion, the benefit to be gained by the
use of the kanamycin resistance marker in transgenic plants is out weighed by
the risk imposed in using this marker and aiding its dissemination nation wide.
If we allow this proposal, we will be adding a tremendous quantitative load of
genetic material to the environment which will probably assure dissemination of
kanamycin resistance.” (13)

FDA Response: The agency approved the use of the kanamycin resistance gene not
only in tomatoes but in other vegetables as well. Consequently, for many years,
most GE foods contained anti-biotic resistance genes. Because most experts have
come to agree that it’s more prudent to employ different markers, changes have
slowly been made to correct a situation the FDA scientists tried to prevent from
happening in the first place.

D. What the FDA says in public
In addition to the false statements noted in the previous sections, the agency
has continued to misrepresent the facts. For example, on February 28, 2000, Dr.
James Maryanski, the agency’s primary spokesperson on GE foods at that time,
responded to revelations in the British press about the memos in the FDA files
while addressing the OECD Conference on GE Food Safety in Edinburgh, Scotland.
He stated that the staff scientists had merely been “asking questions” about the
various issues involved in bioengineered food. But as their own memos clearly
indicate, they were making declarative statements, many of them quite emphatic,
about the unique potential of bioengineering to induce unintended and
unpredictable negative side effects. Further, on May 3, 2000, the FDA
Commissioner declared: “FDA’s scientific review continues to show that all
bioengineered foods sold here in the United States today are as safe as their
non-bioengineered counterparts.” Yet the year before, the FDA acknowledged it
does not perform substantial reviews of GE foods, stating: “FDA has not found it
necessary to conduct comprehensive scientific reviews of foods derived from
bioengineered plants … consistent with its 1992 policy.” (Reported in The
Lancet, May 29, 1999) Moreover, as previously pointed out, the most extensive
test it did review (on the Flavr Savr tomato) raised a safety issue that,
according to its own experts, was never resolved.

E. The FDA has an agenda to promote the U.S. biotech industry

The FDA’s acknowledged policy “to foster” the U.S. biotechnology industry is
part of a broader executive policy that was initiated by the Reagan/Bush
administration – and has continued through each successive administration,
including Clinton/Gore and Obama/Biden. Further, when in 1991 the FDA created a
new position of Deputy Commissioner for Policy to supervise the formulation of
its policy on GE foods, it appointed Michael Taylor, a Washington, D.C. lawyer
who had been representing Monsanto and other members of the biotech industry on
food regulatory issues. During Mr. Taylor’s tenure as Deputy Commissioner,
references to the potential unintended negative effects of bioengineering were
progressively deleted from drafts of the policy statement (over the protests of
agency scientists), and the final statement was issued claiming (a) that GE
foods are no riskier than others and (b) that the agency has no information to
the contrary. (Subsequently, Mr. Taylor was hired by Monsanto as Vice-President
for Public Policy.) Moreover, when Vice-President Dan Quayle introduced the
FDA’s policy statement in 1992, he referred to it as “regulatory relief” for the
industry.